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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K062685
Device Name EBI ARAY SPINAL SYSTEM
Applicant
EBI, L.P.
399 JEFFERSON ROAD
parsippany,  NJ  07054
Applicant Contact debra bing
Correspondent
EBI, L.P.
399 JEFFERSON ROAD
parsippany,  NJ  07054
Correspondent Contact debra bing
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received09/08/2006
Decision Date 10/06/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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